Maxtec MaxO2ME User manual

R230M01 Rev. D
MaxO2ME
OPERATING MANUAL &
INSTRUCTIONS FOR USE
R230P01

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866.4.Maxtec www.maxtec.com
Maxtec TEL [phone]
2305 South 1070 West FAX [phone]
Salt Lake City, Utah 84119 www.maxtec.com
USA
Authorized Representative:
EC REP QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
This manual describes the function, operation and maintenance of the Maxtec Model MAXO2ME
oxygen monitor. The MaxO2ME utilizes the Maxtec MAX-550E oxygen sensor and is engineered for
fast response, maximum reliability and stable performance. The MaxO2ME is designed primarily
for continuous monitoring of oxygen levels delivered by medical oxygen delivery equipment and
respiratory care systems. Adjustable high and low level alarm set points make the MaxO2ME ideal
for use in neonatal, anesthesia and respiratory care.
CLASSIFICATION
Protection Class: ......................................................II, Type B
Ingress Protection Rating: ...................................................IPX2
Mode of Operation: ...................................................Continuous
Sterilization: ......................................................See section 6.0
Safety of application in the presence of a flammable anesthetic mixture:.........See section 8.1
Power specification: ................................7.5V(MAX) 1.9W.250mA(MAX)
CAUTION:Federal law restricts this device to sale by or on the order of a medical professional.
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash disposal. Return
sensor to Maxtec for proper disposal or dispose according to local guidelines. Follow local
guidelines for disposal of other components.
WARRANTY
The MaxO2ME Monitor is designed for medical oxygen delivery equipment and systems. Under
normal operating conditions, Maxtec warrants the MaxO2ME Monitor to be free from defects of
workmanship or materials for a period of two (2) years from the date of receipt from Maxtec, provided
that the unit is properly operated and maintained in accordance with Maxtec’s operating instructions.
Based on Maxtec’s product evaluation, Maxtec's sole obligation under the foregoing warranty is limited
to making replacements, repairs, or issuing credit for equipment found to be defective. This warranty
extends only to the buyer purchasing the equipment directly from Maxtec or through Maxtec's
designated distributors and agents as new equipment. Maxtec warrants the MAX-550E oxygen sensor
in the MaxO2ME Monitor to be free from defects in material and workmanship for a period of two
(2) years from Maxtec's date of shipment in a MaxO2ME unit. Should a sensor fail prematurely, the
replacement sensor is warranted for the remainder of the original sensor warranty period. Routine
maintenance items, such as batteries, are excluded from warranty. Maxtec and any other subsidiaries
shall not be liable to the purchaser or other persons for incidental or consequential damages or
equipment that has been subject to abuse, misuse, mis-application, alteration, negligence or
accident. THESE WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
9700630
Conforms to AAMI STD ES60601-1, ISO STD 80601-2-55,
IEC STDS 60601-1-6, 60601-1-8 & 62366
Certified to CSA STD C22.2 No. 60601-1
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NOTE: In order to obtain optimum performance from your MaxO2ME monitor, all operation
and maintenance must be performed in accordance with this manual. Please read the
manual thoroughly before using the monitor and do not attempt any repair or procedure
that is not described herein. Maxtec cannot warrant any damage resulting from misuse,
unauthorized repair or improper maintenance of the instrument.
WARNINGS
FAILURE TO COMPLY WITH THESE WARNINGS AND CAUTIONS COULD RESULT
IN INSTRUMENT DAMAGE AND POSSIBLY JEOPARDIZE THE WELL BEING OF THE
PATIENT AND/OR HEALTH CARE PROFESSIONAL.
»Before use, all individuals who will be using the MaxO2ME must become thoroughly familiar with
the information contained in this Operation Manual. Strict adherence to the operating instructions
is necessary for safe effective product performance. This product will perform only as designed if
installed and operated in accordance with the manufacturer’s operating instructions.
»This product is not intended as a life-sustaining or life-supporting device.
»Medical Oxygen should meet the requirements of USP.
»The Alarm limits can be set to levels that would render them useless for a particular patient's clinical
condition. Ensure that the delivered oxygen level and flow rate are set to values prescribed by the
patient's physician. Also ensure that the high and low alarm limits are set to levels such that they
will sound if the oxygen level is outside of safe limits. Be sure to review and, if necessary, re-set the
alarm limits when the patient's clinical condition changes or when the patient's physician prescribes a
change in oxygen therapy.
»To avoid explosion, DO NOT operate the oxygen monitor in the presence of flammable anesthetics
or in an atmosphere of explosive gases. Operating the oxygen monitor in flammable or explosive
atmospheres may result in fire or explosion.
»Never allow an excess length of cable near the patient’s head or neck, as such could result in
strangulation. Secure excess cable to the bed rail or suitable object.
»Never use a MaxO2ME monitor with a cable that appears worn, cracked or has damaged insulation.
» The oxygen sensors contain a weak acidic solution encapsulated in a plastic housing. Under
normal operating conditions the solution (electrolyte) is never exposed. In case of a leak or if
damaged, DO NOT use the oxygen sensor.
»Use only genuine Maxtec accessories and replacement parts. Failure to do so may seriously
impair the monitor’s performance. Repair or alteration of the MaxO2ME beyond the scope of the
maintenance instructions or by anyone other than an authorized Maxtec service person could cause
the product to fail to perform as designed. No modification of this equipment allowed.
»Calibrate the MaxO2ME weekly when in operation and if environmental conditions change significantly.
(I.e., Temperature, Humidity, Barometric Pressure. Refer to Calibration section of this manual).
»Use of the MaxO2ME near devices that generate electrical fields may cause erratic readings.
»If the MaxO2ME is ever exposed to liquids (from spills or immersion) or to any other physical abuse,
turn the instrument OFF, remove batteries and allow to dry completely, then power ON. This will allow
the unit to go through its self test and make sure everything is operating correctly.
»Never autoclave, immerse in liquid or expose the MaxO2ME (including sensor) to high temperatures
(>50°C). Never expose the device to liquid, pressure, irradiation vacuum, steam, or chemicals.
»To protect the unit from potential leaky battery damage always remove batteries when the unit is going
to be stored (not in use for 30 days or more) and replace dead batteries with recognized name brand
AA Alkaline batteries.
DO NOT use rechargeable batteries.
» This device does not contain automatic barometric pressure compensation.
» Not for use in an MRI environment.
» Battery replacement by inadequately trained personnel could result in a safety hazard.
» Electrical shock or damage to the equipment may occur if an inappropriate external power
supply is used. Maxtec recommends using only the Maxtec approved external power supply, as
listed in 9.0 Spare Parts and Accessories.
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NOTE: The MaxO2ME oxygen monitor has been manufactured with a low alarm setting
adjustable down to 15% that requires deliberate action to set it below 18%.
See section 3.1 Alarm Setting Procedure.
DO NOT clean or dry the MaxO2ME with a high pressure air gun. Applying high pressure air to
the MaxO2ME may damage components and render the system inoperable.
DO NOT over clean the MaxO2ME. Repeated use of a cleaning agent can cause residue buildup
on critical components. Excessive residue buildup can affect the MaxO2ME's performance.
» When cleaning the MaxO2ME: DO NOT use harsh abrasives. DO NOT immerse the
MaxO2ME in liquid sterilizing agents or liquids of any kind. DO NOT spray cleaning solution
directly onto the device. DO NOT allow cleaning solution to pool on the device.
DO NOT sterilize the MaxO2ME. Standard sterilization techniques may damage the monitor.
»If the MaxO2ME does not function as outlined in section 2.0, contact a Maxtec trained service
technician or Maxtec for service.
DO NOT allow the sensor to come in contact with exhaled patient gases or other potential sources of
contamination. The sensor face cannot be decontaminated if it comes in contact with infectious agents.
»Gas leaks that cause room air to mix with the gas sample may cause inaccurate oxygen readings.
Ensure the O-rings on the sensor and flow diverter are in place and intact prior to use.
DO NOT expose the sensor face to liquids or allow humidity to condense on the face of the
sensor as this may impair the function of the MaxO2ME.
»The MaxO2ME and sensor are non-sterile devices.
»Regularly inspect the MaxO2ME and associated components for damage or electrolyte leakage prior to use.
DO NOT use if damaged.
DO NOT obstruct alarm.
DO NOT smoke in an area where oxygen is being administered.
»The MaxO2ME may only be calibrated using 20.9% oxygen (room air) or 100% oxygen. Calibration at
other concentrations will result in inaccurate readings.
»The MaxO2ME may be used for ground transport but should not be used during air transport as
changes in barometric pressure will alter the monitor readings.
»The oxygen sensor should be operated in an upright position (sensor face downwards).
Operating the oxygen sensor upside down may cause the sensor to function improperly.
»When using the approved external power supply, functional batteries must also be installed in the
device. The device will not operate solely on the external power supply.

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TABLE OF CONTENTS
CLASSIFICATION ............................................... I
WARRANTY ................................................... I
WARNINGS ...................................................II
SYMBOL GUIDE................................................V
1.0 SYSTEM OVERVIEW ..........................................1
1.1 Base Unit Description ............................................1
1.2 Components Identification.........................................2
1.3 MAX-550E Oxygen Sensor ........................................4
2.0 SET-UP PROCEDURE .........................................4
2.1 Battery Installation ..............................................4
2.2 Calibrating the MaxO2ME Monitor ....................................5
2.2.1 Before You Begin ..............................................5
2.3 Set Operating Mode .............................................5
2.3.2 To Calibrate the MaxO2ME Monitor to 20.9% Oxygen ....................5
2.3.3 To Calibrate the MaxO2ME Monitor to 100% Oxygen ....................6
2.3.4 Factors Influencing Calibration ....................................6
3.0 OPERATING INSTRUCTIONS ...................................7
3.1 Alarm Setting Procedure ..........................................7
3.1.1 Low Alarm Setting .............................................7
3.1.2 High Alarm Setting.............................................8
3.1.3 Smart Alarm Mode.............................................8
3.2 Basic Operation ................................................9
3.3 Alarm Conditions and Priorities ......................................9
3.4 Backlight Operation ............................................10
3.5 Sleep Mode Operation...........................................10
3.6 External Power Supply Operation...................................10
4.0 SENSOR REMOVAL AND REPLACEMENT .........................11
5.0 PROBLEM SOLVING .........................................11
6.0 CLEANING AND MAINTENANCE ................................12
6.1 Cleaning .....................................................12
6.2 Alarm Testing .................................................13
6.3 Replacing Sensor Cable .........................................13
7.0 SPECIFICATIONS ...........................................13
7.1 Base Unit Specifications .........................................13
7.2 Sensor Specifications ...........................................14
8.0 APPLICATIONS ............................................14
8.1 Exposure to Anesthetic Gases .....................................14
8.2 Calibration Techniques in Pressurized Systems . . . . . . . . . . . . . . . . . . . . . . . . 14
8.3 Calibration Errors ..............................................15
9.0 SPARE PARTS AND ACCESSORIES ..............................16
9.1 Electromagnetic Compatibility ..................................17

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SYMBOL GUIDE
The following symbols and safety labels are found on the MaxO2ME and/or labeling:
POWER SUPPLY SYMBOL GUIDE
The following symbols and safety labels are found on the MaxO2ME power supply:
EC REP Authorized Representative
in the European Community SN Serial Number
IPX2 Ingress Protection
Rating
REF Catalog Number
Manufacturer
Attention, consult accompanying
documents
Two means of patient
protection (double insulated)
Power Supply Meets CEC Tier
3 and EU Phase 2 Standards
Consult Instructions For Use
Complies with Direective 2011/65/EU
RoHS
Calibration Reminder
Do Not Corrosive
!
Caution
Warning
!
DOWN (LOW ALARM) Key UP (HIGH ALARM) Key
ON/OFF Key Silent Key
Smart Alarm Key
Backlight Key
High Alarm Indicator Low Alarm Indicator
Alarm Silence
Indicator
BUTTON & SCREEN SYMBOL GUIDE
The following symbols are found on the MaxO2ME:
Sleep Mode Indicator
Smart Alarm Mode
Indicator
Low Battery
Indicator
BAT
CAL (Calibration Key)
CAL
Unlock Key
Type B Applied
Parts
Direct
Current
Meets ETL standards
9700630
122˚F
50˚C
5˚F
-15˚C
Storage Temperature Range
122˚F
50˚C
5˚F
-15˚C
Do not throw away. Follow local
guidelines for disposal.
Do not throw away. Follow local
guidelines for disposal.
Conforms to EU requirements
For use in dry indoor locations
Federal law (USA) restricts this device to
sale by or on order of a physician
only
Combined UL / CSA Mark

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1.0 SYSTEM OVERVIEW
1.1 Base Unit Description
The MaxO2ME is a handheld oxygen analyzer/monitor capable of measuring
the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E
oxygen sensor outputs a voltage which is used by the MaxO2ME to determine
the concentration of oxygen based on a calibration at room air or 100%
oxygen. The MaxO2ME contains alarms that can be controlled by the user to
set a maximum or minimum allowable oxygen concentration.
»Oxygen sensor of approximately 1,500,000 O2percent hours.
»External probe with 10 ft., extendable cable and diverter fitting for standard 15 mm "T"
adapter.
»Operation using 4 AA alkaline batteries (4 x 1.5 volts) for approximately 5000 hours of
performance with typical use.
»Oxygen-specific, galvanic sensor that achieves 90% of final value in approximately 15
seconds at room temperature.
»Self-diagnostic check of analog and microprocessor circuitry.
»Low battery indication.
»Calibration reminder timer that alerts the operator, using a calibration icon on the LCD
display, to perform a unit calibration.
»Adjustable high-level and low-level alarming capability with flashing LED and audible
indication of alarm conditions.
»Smart high-low alarm setting to help adjust alarm settings quickly
»Back-light display with auto ambient light level detection.
»Sleep Mode operation to extend battery life.
Indication for Use:
The MaxO2ME oxygen monitor is intended for continuous monitoring of the
concentration of oxygen being delivered to patients ranging from newborns to adults.
It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is
not a life supporting device.

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1.2 Component Identification
<18% Alarm Indicator - The <18% alarm indicator is located above the Low Alarm
Indicator digits. When the low alarm setting is set below <18%, the indicator will flash
each second to alert the operator of this special condition. See section 3.1.1 for setting
this low alarm condition.
Low Alarm LED - In a low alarm condition, the yellow "LOW ALARM" LED will flash once
every two seconds, accompanied by the audio buzzer. If the Oxygen level is below 18%, the
red “LOW ALARM” LED will flash twice per second accompanied by the audio buzzer.
High Alarm LED - In a high alarm condition, the yellow "HIGH ALARM" LED will flash
once every two seconds accompanied by the audio buzzer.
3 1/2-Digit Display - The 3 1/2 digit liquid crystal display (LCD) provides direct
readout of oxygen concentrations. The digits also display error codes, alarm set
modes and calibration codes as necessary.
% Symbol - The "%" sign is located to the right of the concentration number and is
present during normal operation.
Alarm Silence/Smart Alarm Indicator - When the silent key is pressed the indicator
will display with cross bars to alert condition. When Smart Alarm Mode Button is
pressed the indicator will display with T-bars to alert condition.
Low Battery Indicator - BAT The low battery indicator is located at the middle of
the display and is only activated when the voltage on the batteries is below a normal
operating level.
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High Alarm Indicator - The high alarm setting is displayed at all times just below
the "HIGH" icon on the LCD readout. The indicated value represents the oxygen
percentage at which the high alarm will be activated.
Calibration Reminder - The calibration reminder symbol is located at the bottom
of the display. This symbol will be lighted after one week has elapsed from the
previous calibration.
Low Alarm Indicator - The low alarm setting is displayed at all times just below
the "LOW" icon on the LCD readout. The indicated value represents the oxygen
percentage at which the low alarm will be activated.
Up (Alarm High) - The up key is used in setting the high FiO2alarm limit.
The device must be in the unlocked state for the key to operate. See section 3.1.2 for
instructions on setting the high FiO2alarm limit.
Alarm Silence Indicator - In an alarm condition, pressing the SILENT key will
deactivate the audio alarm for 2 minutes.
ON/OFF Key - This key is used to turn the device on or off. To turn the device
OFF, the button must be held while a rapid 3-2-1 countdown takes place to prevent
accidental power-off.
Calibration Key - This key is used to calibrate the device. The device must be in the
un-locked state for the key to operate. See section 2.2.2 for instructions on calibrating.
Down (Alarm Low) - The down key is used in setting the low FiO2alarm limit. The
device must be in the unlocked state for the key to operate. See section 3.1.1 for
instructions on setting the low FiO2alarm limit.
Un-lock Key - The un-lock key is used to unlock and lock the instrument.
Sensor with Diverter - The sensor (with diverter) is designed to fit industry
standard, 15mm I.D. "T" adapters.
Coiled Cable - The coiled cable allows the sensor to be positioned up to 8 feet from
the side of the unit.
Backlight - The backlight key will manually activate the backlight for 30 seconds.
See section 3.4 for more information on backlighting operation.
Smart Alarm - The smart alarm key is used to help set the High-Low Alarm window
quickly. See section 3.1.3 for instructions on using the smart alarm setting.
Sleep Mode Indicator - The sleep mode Indicator is used to help with battery
consumption. See section 3.5 Sleep Mode Operation.
External Supply Port - The port provides connection for the external power supply.
See section 3.6 for more information on the power adapter.
Locking Shroud - Threaded coupler that locks cable to sensor and monitor.
CAL
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1.3 MAX-550E Oxygen Sensor
The MAX-550E is a galvanic, partial pressure sensor that is specific to oxygen.
It consists of two electrodes (a cathode and an anode), a FEP membrane and
an electrolyte. Oxygen diffuses through the FEP membrane and immediately
reacts electrochemically at a gold cathode. Concurrently, oxidation occurs
electrochemically at a lead anode, generating an electrical current and
providing a voltage output. Electrodes are immersed in a unique gelled weak
acid electrolyte which is responsible for the sensors long life and motion
insensitive characteristic. Since the sensor is specific to oxygen, the current
generated is proportional to the amount of oxygen present in the sample gas.
When no oxygen is present, there is no electrochemical reaction and therefore,
negligible current is produced. In this sense, the sensor is self-zeroing.
CAUTION: The MAX-550E oxygen sensor is a sealed device containing a mild acid
electrolyte, lead (Pb), and lead acetate. Lead and lead acetate are hazardous waste
constituents and should be disposed of properly, or returned to Maxtec for proper
disposal or recovery.
CAUTION: Dropping or severely jarring the sensor after calibration may shift the
calibration point enough to require recalibration.
CAUTION: The flow diverter for the sensor is for use with flowing gases only.
DO NOT use the diverter when performing static sampling, such as in incubators, oxygen
tents, oxygen hoods, etc.
2.0 SET-UP PROCEDURE
2.1 Battery Installation
All MaxO2ME units are powered by four, AA, alkaline batteries (4 x 1.5 Volts)
and are shipped without the batteries installed. The battery compartment is
accessible from the back side of the unit. Batteries should be changed by
qualified service personnel. Use only brand name batteries. Replace with four
AA batteries and insert per orientation marked on the device.
To install the batteries:
1.Release the thumb screw by turning it counter-clockwise until it pops out.
2.Install the four, AA, alkaline batteries (4 x 1.5 Volts) in the unit, observing the
orientation shown on the plastic inside the compartment.
3.Slide the battery compartment cover back onto the case. Press in on the
thumb screw while turning it clockwise until it engages the thread in the
enclosure. Turn until it is lightly tightened. DO NOT over-tighten.
WARNING: Battery replacement by inadequately trained personnel could result in a safety
hazard. The MaxO2ME will automatically perform a new calibration any time the batteries are
removed or replaced. Ensure that the sensor is exposed to either 20.9% oxygen (room air) or
100% oxygen when changing the batteries to avoid mis-calibration.
WARNING:Electrical shock or damage to the equipment may occur if an inappropriate
external power supply is used. Maxtec recommends using only the Maxtec approved
external power supply as listed in 9.0 Spare Parts and Accessories.
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When batteries are installed in the MaxO2ME, the unit initiates a self diagnostic
test. All segments of the LCD readout are turned on for approximately 2
seconds. The audio buzzer sounds and the high and low alarm LEDs are
illuminated. When the diagnostic test is completed successfully, the word "CAL"
will display and then automatically initiate a calibration.
2.2 Calibrating the MAXO2ME Monitor
2.2.1 Before You Begin
A protective film covering the threaded sensor face must be removed; wait
approximately 20 minutes for the sensor to reach equilibrium.
Next, the MaxO2ME Oxygen Monitor should be calibrated. Thereafter, Maxtec
recommends calibration on a weekly basis. However, more frequent calibration
will not adversely affect product performance.
Calibration of the instrument should be performed when the temperature of
the gas stream changes by more than 3 degrees Celsius.
Changes in barometric pressure can affect the oxygen reading. A 1% change
in the barometric pressure results in an error of 1% of actual reading (Example:
If you are reading a 50% oxygen mix and the barometric pressure drops from
1000mbar to 990mbar the reading will drop to: 50% x (990/1000) = 49.5%).
Maxtec recommends that you re-calibrate after changing point-of-use elevation
by more than 500 feet (150m).
In addition, calibration is recommended if the user is unsure when the last calibration
procedure was performed or if the measurement value displayed is in question.
It is best to calibrate the MaxO2ME Monitor at a pressure and flow similar to
your clinical application.
NOTE: Before beginning calibration the MAX-550E sensor must be in thermal equilibrium. You
may also need to be aware of other factors which affect device calibration values. For more
information, refer to “Factors Influencing Calibration and Performance” in this manual. The
main display is capable of reading oxygen in the range of 0-105%. This additional range beyond
physically possible concentration is to allow the user to be able to see if the device is reading
accurately by testing in room air or 100% oxygen.
2.3 Set Operating Mode
2.3.2 To Calibrate the MaxO2ME Monitor to 20.9% Oxygen
1. Ensure the sensor is in room air and has had sufficient time to equilibrate
with room temperature.
2. Using the ON/OFF key , make sure the unit is powered on.
3. Allow the oxygen reading to stabilize. This will normally take about 30
seconds or more.
4. Press the Un-lock key to unlock the keypad. Note the LOW, Smart Alarm,
CAL, and HIGH icons will begin to flash indicating the SET OPERATING MODE.

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5. Press the CALIBRATION key on the keypad. The word "CAL" will appear on
the display for approximately 5 seconds and then finish with 20.9%.
6. The unit is now calibrated and in the normal operating mode.
2.3.3 To Calibrate the MaxO2ME Monitor to 100% Oxygen (recommended)
1. Place the external probe in a stream of medical grade USP or greater than 99%
purity oxygen. Expose the sensor to the calibration gas at a regulated pressure and
flow at a rate of 1-10 liters per minute (2 liters per minute is recommended).
2.Using the ON/OFF key , make sure the unit is in the normal operating mode.
3.Allow the oxygen reading to stabilize. This will normally take about 30
seconds or more.
4.Press the Un-lock key to unlock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
5.Press the CALIBRATION key on the keypad. The word "CAL" will appear
on the display for approximately 5 second and then finish with 100.0%.
6.The unit is now calibrated and in the normal operating mode.
CAUTION: The device will assume a percent oxygen concentration when calibrating. Be
sure to apply 100% oxygen, or ambient air concentration to the device during calibration
or the device will not calibrate correctly.
2.3.4 Factors Inuencing Calibration
The primary factors influencing the MaxO2ME Monitor are temperature,
pressure, and humidity.
Effects of Temperature
The MaxO2ME Monitor will hold calibration and read correctly within +/-3%
when in thermal equilibrium within the operating temperature range. The
device accuracy will be better than +/-3% if operated at the same temperature
at which it was calibrated. The device must be thermally stable when
calibrated and allowed to thermally stabilize after experiencing temperature
changes before reading is accurate. For these reasons, the following is
recommended:
1. Allow adequate time for the sensor to equilibrate to a new ambient temperature.
2.When used in a breathing circuit, place the sensor upstream of the heater.
3.For best results, perform the calibration procedure at a temperature close to
the temperature where analysis will occur.
Pressure Effect
Readings from the MaxO2ME Monitor are proportional to the partial pressure
of oxygen. The partial pressure of Oxygen (PO2) is equal to the percentage
of oxygen (%O2) times the absolute pressure (AP) at which the sample
environment is measured (PO2=%O2x AP).
CAL
CAL
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Thus the readings are proportional to the concentration if the pressure is
held constant. Flow rate of sample gas can affect pressure at the sensor in
that back pressure at the sensing point may change. For these reasons, the
following is recommended:
1.Calibrate the MaxO2ME Monitor at the same pressure as the sample gas.
2.If sample gases flow through tubing, use the same apparatus and flow rates
when calibrating as when measuring.
Humidity Effect
The MaxO2ME Monitor can be used in applications where the relative humidity
of the sample gas ranges from 0 to 95%, non-condensing. However, it should
be noted that water vapor exerts its own pressure in the same manner as
oxygen does in a sample gas stream.
For example, if the monitor is calibrated in dry gas and then the gas is
humidified, the monitor will correctly display a reading which is slightly lower
than previously displayed. This is due to the dilution of oxygen in the sample
gas by water vapor.
This fact is important to note in systems where there exist both “wet” and
“dry” gas streams such as in a ventilator circuit. If the monitor is measuring
oxygen on the “dry side” of the ventilator, it will correctly indicate an oxygen
concentration slightly greater than actually found in the “wet side” (delivered
to the patient). The water vapor has diluted the gas stream.
Additionally, gas streams of high humidity may tend to condense on the sensor.
Condensation on the sensor may eventually affect performance. For this reason,
it is recommended that the sensor be mounted in a vertical position, facing
downward to prevent condensate from flowing onto the sensing surface.
3.0 OPERATING INSTRUCTIONS
3.1 Alarm Setting Procedure
3.1.1 Low Alarm Setting
To adjust the low alarm setting:
1.Press the Un-lock key to unlock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the DOWN (LOW ALARM) key on the keypad.
NOTE: the Low Alarm digits begin to flash indicating the Low Alarm manual setting.
3. Use the UP and DOWN keys to set the low alarm to the desired value.
Pressing the arrow keys changes the value in 1% increments. If the keys are held
down for more than 1 second the display will scroll at a rate of 1% per second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest low
alarm value and will revert to normal operation. If this occurs inadvertently, simply repeat
the alarm setting procedure.

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There is a special condition that allows the low oxygen alarm to be set below
18%. To access this condition press the DOWN arrow key for three seconds
while the low alarm reading displays 18%. The alarm setting can now be
adjusted to 17, 16, or 15%. A bar will blink above the setting to provide further
indication that the alarm has been set to this special <18% condition.
The low alarm value cannot be set lower than 15%, nor can it be set closer
than 1% from the high alarm value. For example, if the high alarm is set at
25%, the system will not accept a low alarm setting greater than 24%.
4.When the low alarm value is set, press the Un-lock key to accept the low
alarm setting and return to normal operation.
NOTE: The default low alarm setting is 18% O2. Removing the batteries or shutting the unit
OFF will reset the low alarm limit to 18% if it is set to <18%.
3.1.2 High Alarm Setting
To adjust the high alarm setting:
1.Press the Un-lock key to unlock the keypad. Note the LOW, SMART ALARM,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the UP (HIGH ALARM) key on the key pad.
NOTE: The High Alarm digits begin to flash indicating the High Alarm manual setting.
3. Use the UP and DOWN keys to set the high alarm to the desired value.
Pressing the arrow keys changes the value in 1% increments. If the keys are held
down for more than 1 second the display will scroll at a rate of 1% per second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest high
alarm setting and will revert to normal operation. If this occurs inadvertently, simply repeat
the alarm setting procedure.
When the high alarm setting is set above 100% the high alarm will indicate two
dashes - -. This special condition turns off or deactivates the high alarm.
4.When the high alarm value is set, press the Un-lock key again to accept
the high alarm setting and return to normal operation.
NOTE: The default high alarm setting is 50% O2. Removing the batteries will reset the high
alarm limit to 50%.
3.1.3 Smart Alarm Mode
1.Press the Un-lock key to un-lock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the Smart Alarm key on the keypad. Note the LOW digits, Alarm Mode
and HIGH digits begin a slow flash indicating SMART ALARM MODE. The high
alarm will now be set to be equal to the current oxygen reading +3% (rounded
to the nearest interger). The low alarm will now be set to be equal to the current
oxygen reading -3% (rounded to the nearest integer but never lower than 18%).

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3.Pressing the Up key will add one to the high alarm setting and subtract one
from the low alarm setting. Pressing the Down key will subtract one from the
high alarm setting and add one to the low alarm setting. In other words, the Up
Arrow widens the alarm band and the down arrow tightens the alarm band. This
feature will not set the alarm levels above 100% or below 18%.
4.Once the desired alarm settings are attained, press the Un-lock key to
save the settings and return to normal operation mode. If 30 seconds elapse
without a key press by the user, the device will automatically save the new
alarm settings and return to normal operation mode.
3.2 Basic Operation
To check the oxygen concentration of a sample gas:
1.Using the ON/OFF key , make sure the unit is in the power on mode and
properly calibrated.
2.Place the external flow diverter in the sample gas stream. When using a
standard "T" adapter, make sure the sensor is mounted in the adapter
with the flow diverter pointing downward. This will prevent moisture from
potentially draining into the sensor membrane.
NOTE: It is important that a tight fit exists between the diverter and the "T" adapter.
3.Initiate flow of the sample gas to the sensor.
3.3 Alarm Conditions and Priorities
In the event of either a low alarm or high alarm condition, the corresponding
LED will begin to flash, accompanied by the audio buzzer. Pressing the SILENT
key will deactivate the buzzer but the LED and the alarm value digits on the
display will continue to flash until the alarm condition has been rectified. If the
alarm condition still exists 120 seconds after silencing the audio buzzer, the
beeper will start to sound again.
A low alarm condition will remain until the actual concentration is 0.1%
higher than the low alarm setting. A high alarm condition will remain until
the the actual concentration is 0.1% lower than the high alarm setting.
To help differentiate the level of severity, the Monitor provides three unique
audible sequences.

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3.4 Backlight Operation
To turn on the backlighting:
1. When the unit is on, pressing the Backlight key will turn the backlighting
on for 30 seconds. Additional presses will turn off the backlighting.
2. If the device is being used in a dark location, press any key to activate the back light.
CAUTION: Excessive use of the backlight can reduce the life of the batteries.
3.5 Sleep Mode Operation
To use the sleep mode function:
1. Remove the batteries from the unit.
2. Locate the sleep mode switch in the battery compartment and set to the ON position.
3. Replace the batteries in the unit.
The unit will now perform a normal boot-up operation with sleep mode
enabled. With sleep mode enabled the unit will function with all the same
parameters as outlined above with one new feature. While in the ON mode, the
unit will time-out after 90 seconds to a battery saving condition. This condition
will be indicated by a crescent moon on the display. While in this condition
any key that is pressed will return the unit to the ON mode and reset the 90
second time-out counter. In sleep mode, the device will continue to monitor
the oxygen level and will activate the alarm if an alarm condition occurs.
3.6 External Power Supply Operation
To extend the life of the batteries a Maxtec approved external power supply
can be purchased. Once connected to the unit, total power is supplied by the
external power supply. The batteries are still required to be in the unit and will
provide emergency power in the event main AC power is lost.
Alarm Alarm Priority
Low Alarm
LED
(add symbol)
High Alarm
LED
(add symbol)
Audible Alarm Audible Alarm
Repeat
Line Power Plugged In
Line Power Unplugged
External DC Power Supply
voltage out of range
Battery Voltage too low for
device to operate (E04)
Oxygen level above the high
oxygen alarm setting
Oxygen level below the low
oxygen alarm setting
Oxygen level below the low
oxygen alarm setting and
lower than 18%
Informational
Informational
Informational
Medium
Medium
Medium
High
Off Off
Single Yellow
Pulse
Single Yellow
Pulse
Solid Yellow Solid Yellow
Pulsing Yellow Pulsing Yellow
Pulsing Yellow
Off
Off
Off
Pulsing Yellow
Pulsing Red
2 Pulses
2 Pulses
2 Pulses
3 Pulses
3 Pulses
3 Pulses
5+5 Pulses
No Repeat
No Repeat
Every 15 Sec.
Every 15 Sec.
Every 25 Sec.
Every 25 Sec.
Every 25 Sec.
!

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NOTE: Use only the Maxtec approved external power supply in Section 9.0 Spare Parts and
accessories.
NOTE: The power supply is not a battery charger. DO NOT use rechargeable batteries.
4.0 SENSOR REMOVAL AND REPLACEMENT
The MaxO2ME is shipped with a new MAX-550E oxygen sensor.
Although the sensor has a very long expected life, eventually the sensor will
require replacement. Removing or installing a sensor, when necessary, is a
very simple procedure.
To remove and install a new sensor:
1.Grasp the sensor in one hand and, with the other hand, unscrew the cable
connector counter-clockwise at the sensor.
2.Pull out the cable connector plug from the expired sensor.
3.Unscrew the flow diverter from the sensor and discard the expired sensor or
return it to Maxtec for proper disposal.
NOTE: The sensor contains lead and lead acetate, be sure to dispose of expired sensors in
accordance with hospital, local, state and federal regulations.
4.Remove the new sensor from the packaging and remove the protective film
from the sensor face.
5.Insert the cable connector plug into the receptacle of the new sensor and
tighten the cable connector.
6.Screw the flow diverter onto the new sensor.
7.Wait approximately 20 minutes for the sensor to reach equilibrium.
8.Calibrate the new sensor.
NOTE: If the monitor is on when the sensor is detached and replaced, the monitor will
automatically force a re-calibration. The display will read “CAL”.
NOTE: If the cable locking nut is not fully fastened onto the sensor, then the sensor may not
function properly.
5.0 PROBLEM SOLVING
The MaxO2ME monitors have a self test feature built into the software to detect faulty
calibrations, oxygen sensor failures, and low operating voltage. These are listed below,
and include possible actions to take, if an error code occurs.
NOTE: The operator must be facing the device and positioned within 4 meters to distinguish
the visual alarm indicators. Audible alarms can be distinguished as long as the operator is in
the same room and the ambient noise level is typical for a clinical setting.
»Low Battery Icon : If the low battery icon is displayed on the LCD readout at any time,
the batteries should be replaced as quickly as possible.
»E01: Calibration error, sensor output lower than expected. See note below.
»E02: No Sensor Attached, disconnect and reconnect external sensor. Unit should perform
BAT

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an auto calibration, and should read 20.9%. If not, contact Maxtec's Customer Service
Department for troubleshooting
»E03: No Valid Calibration Data Available, make sure unit has reached thermal equilibrium
and perform a calibration routine.
»E04: Battery Below Minimum Operating Voltage, replace batteries. A medium priority
alarm will sound every 25 seconds until the batteries are replaced or become too dead to
sound the alarm.
»E05: Calibration error, sensor output higher than expected. See note below.
»E06: Non-compatible oxygen sensor.
»E07: Calibration error, sensor output is not stable. See note below.
»E08: Calibration error, battery too low to preform calibration. Replace batteries and re-calibrate.
NOTE: If you receive a E01, E05, or an E07 error code, correct by ensuring the calibration
gas is either room air or 100% oxygen. Also ensure the calibration gas flow, pressure and
concentration is constant. Allow sufficient time for the sensor to stabilize in the calibration
gas and with room temperature, then attempt to calibrate again.
If these steps do not correct the error, contact Maxtec for technical support.
NOTE: Use only a Maxtec approved Max-550E sensor called out in Section 9.0 of the Spare
Parts List. The Max550E sensor is equipped with an authentication chip to ensure the
monitor is used with an approved sensor.
After replacing a sensor, if an E06 or E07 is being displayed, please follow the
steps below to clear the error.
1. Disconnect the sensor and reconnect, making sure the male plug is fully
inserted into the receptacle before tightening the threaded locking shroud.
The analyzer should now perform a new calibration with the error cleared.
2. If the error still persists, remove the batteries and reinstall to reset the device.
The analyzer will perform a new calibration with the error cleared.
3. Contact Maxtec Customer Service Department if the error code cannot be cleared.
6.0 CLEANING AND MAINTENANCE
6.1 Cleaning
The external surfaces of the device and its accessories can be cleaned and
disinfected using the process detailed below. Under normal use conditions, the
surfaces of the sensor and T-adapter / flow diverter that come in contact with gas
delivered to the patient should not become contaminated. If you suspect that the
sensing face of the sensor or internal surfaces of the T-adapter / flow diverter have
become contaminated, these items should be discarded and replaced. Store the
MaxO2ME in a clean, dry location when not in use.
1.Using Super Sani-Cloth germicidal disposable wipes (medical grade 2-in-
1 cleaning / disinfecting wipes) remove all visible contamination from the
external surfaces of the device and its accessories. Be sure to closely
inspect and remove contamination from seams and recesses on the device
that may trap contaminants.